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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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April 27, 2007 Approval Letter - Humate-P

Our STN: BL 103960/5243

ZLB Behring L.L.C.
Attention: Paul R. Hartmann R. Ph.
1020 First Avenue, P.O. Box 61501
King of Prussia, Pennsylvania 19406-0901

Dear Mr. Hartmann:

We have approved your request to supplement your biologics license application for Antihemophilic Factor/von Willebrand Factor Complex (Human) to add an indication for adult and pediatric patients with von Willebrand disease for the prevention of excessive bleeding pre and post surgery.

Please submit all final printed labeling at the time of use and include implementation information on FDA Form 356h. Please provide a PDF-format electronic copy as well as original paper copies (ten for circulars and five for other labels). In addition, you may wish to submit draft copies of the proposed introductory advertising and promotional labeling with an FDA Form 2253 to the Center for Biologics Evaluation and Research, Advertising and Promotional Labeling Branch, HFM-602, 1401 Rockville Pike, MD 20852-1448. Please submit your final printed advertising and promotional labeling at the time of initial dissemination, accompanied by an FDA Form 2253.

We will include information contained in the above-referenced supplement in your biologics license application file.

Sincerely yours,

--- signature ---

Basil Golding, M.D.
Director
Division of Hematology
Office of Blood Research and Review
Center for Biologics Evaluation and Research

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448